General Surgery Clinical Trial
Official title:
Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery
Verified date | January 2018 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will evaluate whether information on postoperative ambulation from Fitbits can improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged length of stay, 30-day readmissions, and discharge to transitional care after major surgery.
Status | Completed |
Enrollment | 135 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older - Undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement - Able to provide informed consent Exclusion Criteria: 1. Unable to provide consent 2. Not undergoing procedure of interest 3. Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation) 4. Use of walker, cancer, or wheelchair at baseline 5. Presence of physical limitations on walking (i.e. amputation) 6. Usual place of residence is skilled nursing facility 7. Cognitive inability to follow directions to maintain biosensor in place 8. Unable to place biosensor on patient's wrist |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Location of disposition | Home, Rehab Facility, or Skilled Nursing Facility | Through study completion, on average 1 week | |
Primary | 30-day readmission | Presence or absence of readmission to hospital or ER visit within 30 days of discharge. | 30 days post discharge | |
Primary | Number of steps | Number of steps per day during hospitalization, per Fitbit data. | Through study completion, on average 1 week | |
Primary | Active minutes | Active minutes per day during hospitalization, per Fitbit data. | Through study completion, on average 1 week | |
Primary | Physician daily assessment of ambulatory status | Physician daily assessment of ambulatory status | Through study completion, on average 1 week | |
Primary | Length of stay | Days from admission (end time of surgery) until discharge from hospital. | Through study completion, on average 1 week |
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